The Development of a Risk Evaluation Mitigation Strategy for Extended-Release Opioids

The Food and Drug Administration (FDA) has been mandated by Congress to develop a Risk Evaluation Mitigation Strategy (REMS) for extended-release opioid analgesic medication. The purpose of the REMS policy is to reduce abuse, misuse, addiction, and overdose, and death, while maintaining access to these medications. RSDSA has participated in many conference calls with other organizations and James Broatch, RSDSA’s Executive Director participated in a May 5 invitation-only meeting with FDA staff regarding the REMS. Currently, the FDA is soliciting public comment. The deadline for submitting comments is June 30, 2009. You may submit electronic comments to http://www.regulations.gov. All comments should be indentified with the docket number FDA-2009-N-0143.

A major part of the new program will be efforts to educate doctors and pharmacists about appropriate prescribing of the products. There will be no immediate changes for prescribers or users of extended-release pain medications. Other analgesic medications that are short-acting and more commonly prescribed for pain are not included in the proposed REMS.

View a list of possible affected medications here: http://www.rsds.org/5/news/2009/June/PDF/Opioids_REMS.pdf

Although RSDSA recognizes that the abuse and misuse of opioid medicines is a serious issue with devastating consequences, we maintain that approaches to mitigating this abuse must be balanced with the fact that there are millions of people who rely upon prescription opioid medication to live normal lives. REMS must protect and not interfere with access for people with chronic pain to these important medicines. Negative stereotypes about people suffering with chronic pain and fear of ramifications of opioid prescribing can prevent early and aggressive treatment. Current state, legal, and regulatory policies can interfere with the medical use of appropriate opioid medicines for pain relief. The FDA should not implement any strategies that further interfere with the ability of prescribers and other appropriate healthcare practitioners to responsibly develop, provide, and adjust pain-care management regimens for their patients, including regimens that utilize opioid medication.

Patient education efforts need to focus on the safe use, safe storage, and safe disposal of medicines to prevent prescription opioid medication from entering illicit channels of distribution. Restrictive, punitive systems such as patient “registries” further stigmatize people with pain, create additional hardships, and create new barriers to effective pain care.

At the public hearings, there has been a loud anti-opioid sentiment voiced by individuals who have lost a loved one to an illegally used and abused prescription medication and believe that opioids are overprescribed. One individual even equated Oxycontin with heroin. 

RSDSA wants to encourage individuals who currently take extended-release opioid prescriptions for their chronic pain to share their experience with the FDA.  Daily, RSDSA hears desperate pleas from individuals throughout the country who cannot locate a pain specialist or a primary-care physician who will prescribe analgesic medication for their unrelenting pain or a pharmacy which will fill the prescription.

We encourage you to raise your voice and advocate that the FDA balance the legitimate needs of people with chronic pain as they develop the REMS program and not create new barriers which result in decreased access to these life-saving medicines.

June 1, 2009